Application 208478

Type: ANDA
Sponsor: PERRIGO R AND D

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 10MG BASE	No	No
002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 20MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208478-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL			2020-06-23
A208478-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL			2020-06-23

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`bb7c543d1eb4…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 13 · 256 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Quallent	f00a83aa-3f1d-566d-b9bb-f396f22a27cb	2026-09-08	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Apotex Corp.	d9adb9e4-c495-9530-e5e3-7e3b01d53e4c	2026-09-08	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	604a011e-6c64-4895-8f6e-d28f119c4c22	2026-09-04	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	57f9b462-f08e-483c-9b64-b7e4c8d46927	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	St. Mary's Medical Park Pharmacy	2e20a00c-b373-3a8c-e063-6294a90a637b	2026-08-25	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	634ec8e3-6d83-4cb2-90a3-fc9c973b06bf	2026-08-21	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	d57720ab-9f83-4da9-a57f-0d55e00a605c	2026-08-17	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	ScieGen Pharmaceuticals, Inc.	f2d8b5e9-6ff2-4efa-ab01-e13df29f7371	2026-08-07	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	5b3c3043-9af6-48eb-8b10-528e58c88e48	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	51e24220-3374-4e5e-9a8d-4113002c5bed	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	b0bbab86-6789-4ffb-8f84-ee91b69fdb34	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	9786388d-ac8d-4646-9fe4-b33e8fda86b2	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	09cb8375-075c-47e8-a4eb-8ac667ed849e	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Cardinal Health 107, LLC	aee307d6-b3fa-424f-8656-1f30ff413e95	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	e74278b6-31fc-48d4-97b7-ba500e9e15fb	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Cardinal Health 107, LLC	fbd1c5da-67fb-4412-acb5-4d4c74a43654	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	Macleods Pharmaceuticals Limited	7bd0f0ec-f7a3-4403-9a1a-11f18213631f	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Direct_Rx	56a9e58f-567e-30cc-e063-6294a90a290f	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	2e583569-499d-4f20-87ca-84e7d9868d22	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NORTHSTAR RX LLC	52d8508b-aa98-cd89-5991-e2b5f982b6c6	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM

Application 208478

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#